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Trilogy100 Ventilator, Germany-Rental
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref R1054097
Identity
- Trade Name
- Trilogy100 Ventilator, Germany-Rental EUDAMEDTrilogy FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Trilogy 100, Trilogy EC EUDAMEDTrilogy100 Ventilator, Rental, German version FDA UDI
- Model / Reference
- R1054097 EUDAMED00 FDA UDI
- Description
- Trilogy100 Ventilator, Rental, German version FDA UDI
Identifiers
- Catalog Number
- R1054097 FDA UDI
- Primary DI / UDI-DI
- 00606959026285 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959026285 EUDAMED
- 510(k) Number
- K083526 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Trilogy100 Ventilator, Germany-Rental by Respironics, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959026285 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 6a24e81c-bca9-4ef1-a8d2-f252bd0e78f2 61 fields · synced Aug 3, 2026
- FDA UDI e22e00ab-53d5-41fd-95c8-684903d6c5c1 37 fields · synced May 30, 2026
- EUDAMED 263fc22c-e579-4aa5-a6f3-f707c4483ee4 61 fields · synced Aug 3, 2026